The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Peanut Growth Control Plating System.
| Device ID | K093880 |
| 510k Number | K093880 |
| Device Name: | PEANUT GROWTH CONTROL PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304532373 | K093880 | 000 |
| 00880304492530 | K093880 | 000 |
| 00880304491526 | K093880 | 000 |
| 00880304374164 | K093880 | 000 |
| 00888480237334 | K093880 | 000 |
| 00888480237327 | K093880 | 000 |
| 00888480237310 | K093880 | 000 |
| 00888480237303 | K093880 | 000 |